Deployment catheter

ABSTRACT

A deployment catheter is described herein that preferably is configured to deliver a medical device such as a valve to a location in a patient such as a patient&#39;s airway. Preferably, such a deployment catheter is configured to be used in conjunction with a bronchoscope. In some embodiments, a locking lever is provided to reduce the likelihood of accidental deployment of the device, and which resets conveniently after use to as to permit multiple device deployments.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/107,564, filed on May 13, 2011, which is incorporated in its entiretyby reference herein. Any and all priority claims identified in theApplication Data Sheet, or any correction thereto, are herebyincorporated by reference under 37 CFR 1.57.

BACKGROUND OF THE INVENTION

Field of the Invention

Embodiments of the invention generally relate to the field of medicaldevices, and in particular, to methods, systems, and devices fordeploying and/or implanting a device such as a valve or other medicaldevice into a body by using a catheter.

Description of the Related Art

The incidence, prevalence, and costs of pulmonary diseases such as COPD,chronic bronchitis, and emphysema have increased. New treatment methodsinclude lung volume reduction treatment with minimally-invasivenonsurgical options. In these cases, valves may be implanted into thelungs of a patient to reduce lung size and/or treat air leaks. There istherefore a need for an apparatus and method to safely and consistentlyimplant such valves or other medical devices into patient airways inorder to treat lung conditions.

SUMMARY OF THE INVENTION

Embodiments of the invention generally relate to devices, systems, andmethods for introducing a medical device such as a valve into a body viaa catheter. A catheter is a tube that can be inserted into a body, orbody cavity, duct or vessel. Catheters can be used to allow for drainageor injection of fluids to the body, or to provide access into the bodyby surgical instruments and/or implantable devices. In order to deliveran implantable device into a body, an implantable device may first beinserted into a catheter. To deliver the device to a suitable location,for example to an air passage in a lung, a bronchoscope or other devicemay be provided with a working channel into which the catheter may beintroduced. Delivery and deployment of the device inserted in thecatheter can then take place. In a preferred embodiment, a catheterloaded with a valve delivers the valve to a location in a lung airway.

A valve or other medical device, deployable or otherwise, can beintroduced into a catheter or other deployment apparatus using themethods, systems, and devices described herein. The valve or othermedical device can be implanted or positioned within a patient using acatheter or other deployment apparatus after the valve or other medicaldevice has been loaded into the catheter or other deployment apparatus.Preferably, the valve or other medical device is loaded into a cavity orother space provided in the distal tip region of the catheter or otherdeployment apparatus. In some embodiments, the catheter or otherdeployment apparatus may be loaded into the working channel of abronchoscope or other such apparatus and navigated to a suitabledeployment location, for example a patient's airway.

Embodiments of the apparatus may have additional features, either aloneor in combination, that may prove advantageous and useful in aidingdeployment. For example, a lockout lever may be provided that reduces oreliminates the likelihood of accidental deployment of a valve or otherdevice, and which may also reset after deployment so as to facilitatemultiple device deployments. Additionally, a grip, which can in someembodiments be shaped as a C-handle, may be provided that can be clippedonto a bronchoscope to assist in deployment of a valve or other device,while also providing an ergonomic handle. Localization markers may alsobe provided on the apparatus, and in particular near its distal end, andwhich may aid an operator in aligning the implantable device with achosen deployment site. The distal tip portion may also be constructedin a cage-like structure, and may also be provided with one or morefenestrations that may permit visualization of and confirmation that thevalve or medical device has been correctly loaded into the distal tip.Of course, additional features and details will be discussed in greaterdetail herein.

In one embodiment, a deployment catheter for deploying a device into alung is described, where the deployment catheter comprises:

a proximal end comprising a handle portion, the handle portioncomprising a plunger, the plunger being surrounded by a movable handle,the movable handle configured to be slid axially in a direction along atleast a portion of the length of the plunger, and wherein the plungerfurther comprises a locking lever capable of switching between lockedand unlocked positions, the locking lever configured to prevent themovable handle from sliding in a proximal direction toward the plungerwhen in the locked position, but configured to permit the movable handleto slide in a proximal direction when in the unlocked position, andwherein the locking lever is further configured to reset to a lockedposition;

a catheter shaft portion, the catheter shaft portion comprising acatheter shaft and a stabilization wire inside the catheter shaft,wherein the catheter shaft is secured to the movable handle at theproximal end of the catheter shaft, and wherein the stabilization wireis secured to the plunger; and

a distal tip portion configured to receive a medical device in a cavity,wherein the distal tip portion is secured to the distal end of thehollow catheter shaft, and which further comprises a pusher plungerreceived within the cavity, the pusher plunger connected to the distalend of the stabilization wire.

Some embodiments provide for the proximal plunger to comprise a C-shapedhandle on its proximal end. In some embodiments, the locking levercomprises a locking tab configured to engage with a recess in themovable handle. The locking lever may also comprise a spring attached tothe locking lever configured to reset the locking lever to a lockedposition after the medical device has been deployed from the deploymentcatheter.

In some embodiments, the catheter shaft portion comprises a highflexibility region at its distal end, which may comprise a jigsawconfiguration, a serpentine configuration, or overlapping straight cuts.

Further embodiments provide for the distal tip portion to comprise acage with at least one cavity configured to receive a medical device.The cage may have an arrangement of struts forming a spiralconfiguration, and may comprise one or more large fenestrations. In someembodiments, the one ore more large fenestrations are configured topermit visualization and confirmation that the medical device has beenloaded into the cavity. The distal tip portion may also comprise atleast one localization marker configured to indicate the approximatedeployment location of the medical device. In some embodiments, thelocalization marker is yellow and flanked by two additional black bands.In some embodiments, the distal end of the catheter shaft portionfurther comprises at least one long localization marker.

In some embodiments, the handle portion further comprises afrustroconical strain relief surrounding a proximal region of thecatheter shaft portion. Some embodiments may also comprise an outersheath surrounding at least a proximal region of the catheter shaftportion. Preferred embodiments may be configured to be loaded within abronchoscope.

A further embodiment provides for a method of deploying a medical devicein a patient lung, where the method comprises:

loading the medical device into a cavity disposed in the distal tipportion of a deployment catheter;

introducing the deployment catheter into a bronchoscope;

inserting the bronchoscope into a lung airway;

navigating the bronchoscope to a portion of the lung airway to betreated;

aligning the portion of the lung airway to be treated with at least onelocalization marker disposed on the distal tip portion of the deploymentcatheter;

unlocking a locking lever on the deployment catheter; and

deploying the medical device to the portion of the lung airway to betreated.

In some embodiments, the locking lever resets to a locked position afterdeployment of the device. In further embodiments, the deploymentcatheter comprises a C-shaped handle on its proximal end, and whereinthe C-shaped handle is attached to a portion of the bronchoscope. Inadditional embodiments, the step of navigating the bronchoscope furthercomprises tracking the deployment catheter using radio imaging means.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIG. 1 illustrates a side view of an embodiment of a catheter.

FIG. 2 illustrates a close-up side view of an embodiment of the handleportion of the catheter.

FIGS. 3-4 respectively illustrate top and bottom views of an embodimentof the handle portion of the catheter.

FIGS. 5A-B illustrate left and right views of an embodiment of thecatheter.

FIG. 6 illustrates a cross section of an embodiment of the cathetershaft.

FIG. 7 is a cross-section of an embodiment of the handle portion of thecatheter.

FIG. 8 illustrates a close-up cross-section view of an embodiment of thecatheter lockout mechanism.

FIGS. 9A-B illustrate close-up views of a fork attaching the cathetershaft onto an embodiment of a catheter handle.

FIGS. 10A-C illustrate embodiments of a high flexibility region presenton a catheter shaft.

FIGS. 11A-B respectively illustrate close-up views of an embodiment ofthe distal tip of the catheter without and with a valve loaded therein.

FIGS. 12A-B respectively illustrate close-up cross-section views of anembodiment of the distal tip of the catheter without and with a valveloaded therein.

FIG. 13 is a close-up view of the extreme end of the distal tip of anembodiment of the catheter.

FIG. 14 illustrates an embodiment of a connector mechanism that may beused to attach a distal tip to a catheter shaft.

FIG. 15 illustrates a close-up view of a distal tip of an embodiment ofthe catheter shaft with locator markings added thereto.

FIGS. 16A-H illustrate various embodiments of a distal tip of thecatheter.

FIG. 17 is a view of an embodiment of a packaged catheter and valveloader system.

FIG. 18A illustrates an embodiment of the catheter loaded into abronchoscope inserted into a lung airway.

FIG. 18B illustrates an embodiment of a catheter with a grip attached toa bronchoscope.

FIGS. 19A-C illustrate how a lockout mechanism present in an embodimentof the catheter handle operates.

FIGS. 20A-C illustrate the deployment of a valve into an airway using avalve loaded into an embodiment of the catheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A catheter deployment system and its related components and parts nowwill be described with reference to the accompanying figures of one ormore embodiments. The terminology used in the description presentedherein is not intended to be interpreted in any limited or restrictivemanner. Rather, the terminology is simply being utilized in conjunctionwith a detailed description of embodiments of the systems, methods andrelated components. Furthermore, embodiments may comprise several novelfeatures, no single one of which is solely responsible for its desirableattributes or is believed to be essential to practicing the inventionsherein described.

The terms “valve,” “deployable medical device,” and “medical device” and“device” as used herein are broad interchangeable terms and, unlessotherwise indicated, the terms can include within their meanings,without limitation, stents, valves, lung reduction valves, balloons,probes, markers, including radioopaque markers and other forms offiducial markers, anchors, or any other medical device, deployable orotherwise, that is configured to be loaded or introduced into a catheteror other deployment apparatus and subsequently delivered or deployed.Although some embodiments described herein refer to deploying a medicaldevice into an airway, this disclosure is not so limited, and deploymentcould be made, for example but without limitation, into other vessels,passages, and body cavities in humans and animals. In certainembodiments, the valve and/or medical device is the type disclosed inU.S. Pat Nos. 6,293,951 or 7,757,692, each of which is herebyincorporated in their entirety.

FIG. 1 illustrates an embodiment of a deployment catheter system 101.This system 101 comprises several different portions functioningtogether. A proximal end of the system 101 comprises a handle portion103, which is coupled to a catheter shaft portion 105, terminating witha distal tip portion 107 at a distal end of the system 101. In apreferred embodiment, the proximal handle portion 103 is connected viathe catheter portion 105 to the distal tip portion 107, which preferablycontains a medical device to be deployed to a suitable site using thesystem 101. In some embodiments, the distal tip portion 107 may contain,or be configured to receive, a device such as a valve to be deployed inan airway passage.

FIGS. 2-5 illustrate additional exterior views of the handle portion103. The handle portion 103 preferably is adapted to be held or grippedby a user, and comprises several parts. The handle portion 103 comprisesa grip 202 that is connected to a plunger 204. A movable handle 206 isattached to, and may for example be disposed around, the plunger 204.The catheter shaft portion 105 is connected to the handle portion 103 atthe distal end of the handle portion 103.

The grip 202 of the handle portion 103 may be constructed with a recess,which can permit the handle portion 103 to be held or engaged by thethumb of a user when about to deploy a device contained in the distaltip portion 107. As illustrated, the grip 202 may form a C-shaped grip.The grip 202 may take other shapes, for example but without limitation,the grip 202 may have an inner surface that is U-shaped, V-shaped, orrecessed. In some embodiments, and as described below in further detailin FIG. 18B, the grip 202 may be attached to a device such as anendoscope, or more particularly a bronchoscope. The grip 202, as well asother parts of the system 101 that may be held or manipulated by thehand of a user, may be provided with a non-slip or rubberized coating toprovide additional grip for a user.

The grip 202 is attached to the plunger 204. The plunger 204 may beprovided with ergonomic finger knurlings 205 that can provide a moresecure or comfortable grip for a user's fingers when operating thesystem 101.

The movable handle 206 is configured to movably engage with the plunger204, such that the movable handle 206 can, for example, slide back andforth in a longitudinally axial direction along at least a portion ofthe plunger 204. From the position illustrated in FIG. 2, the movablehandle 206 may move in a proximal direction toward the grip 202.

Distal to the movable handle 206, a securement tab 208 and a lockinglever 210 may be attached to the plunger 204. The locking lever 210 isconfigured, when in the locked position illustrated, to engage with themovable handle 206 so as to reduce or eliminate the likelihood of themovable handle 206 moving in a proximal direction toward the grip 202.The movable handle 206 preferably comprises ergonomic aids, such as aridge 207, that enable a user to easily manipulate and pull on themovable handle 206 during deployment of a medical device. In someembodiments, all or a portion of the movable handle 206 may be providedwith a non-slip or rubberized coating to provide additional grip for auser.

The handle portion 103 may also comprise a strain relief component 212.Preferably, this strain relief component 212 couples to the handleportion 103 and is constructed from a resilient material, such aspolymers including, for example but without limitation, rubber,thermoplastic elastomers (e.g., Santoprene™, Kraton®), polyurethane,polyvinyl chloride, PEBAX®, and silicone. The strain relief component212 may be approximately conical or frustoconical in shape with acentral opening extending lengthwise and configured to have closecompliance with an outer sheath 316 (if so provided) or a catheter shaft302 of the catheter shaft portion 105. The strain relief component 212may reduce the likelihood of kinking or bending of the catheter shaftportion 105 near the point where the catheter shaft portion 105 meetsthe handle portion 103, and in particular when the catheter shaftportion 105 is inserted into instruments such as a bronchoscope andmanipulated during use.

With reference now to FIG. 6, a cross-section of the catheter shaftportion 105 is illustrated. The catheter shaft 302 is hollow andcomprises a stabilization wire 304 extending longitudinally within it.The catheter shaft 302 preferably is constructed from a resilient androbust material, such as a metal or metals, that is resistant toelongation and plastic deformation while remaining flexible enough to beguided through tortuous passages and other similar constrictions.Suitable metals may include stainless steel, Nitinol, and the like. Insome embodiments, polymer tubing may function satisfactorily, andembodiments may be manufactured, for example, from continuous polymerextrusions. These extrusions may also incorporate braids for additionalstrength and durability, and may be constructed from polymers such aspolyimide. The stabilization wire 304 may likewise be constructed fromsimilar materials.

In some embodiments, a lubricious coating or material may be added toeither or both the stabilization wire 304 or the catheter shaft 302,which can aid the two parts in sliding past each other more freely andgenerally without binding or sticking. For example, polymers such asPTFE or parylene may be coated onto the stabilization wire 304. Coatingssuch as FEP can also be extruded onto the stabilization wire.Heat-shrink polymers such as PTFE or polyethylene may also be added tothe stabilization wire 304.

In some embodiments, it may be preferable for the stabilization wire 304to have a varying diameter along its length. This diameter may change,for example in a continuous or tapering manner, or in a stepwise manner.Without wishing to be bound by theory, it is believed that someembodiments of the stabilization wire 304 may benefit from having athicker diameter at the proximal end (i.e., toward the handle portion103) so as to reduce or eliminate the likelihood of buckling underhigher applied loads, while having a thinner diameter toward the distalend (i.e., near the tip portion 107) so as to provide additionalflexibility. In one embodiment, the stabilization wire 304 has adiameter of 0.020 inches from the proximal end until approximately oneinch past an outer sheath 316. The remainder of the stabilization wire304 has a stepwise change in diameter to 0.016 inches. This embodimentmay be used in a catheter shaft 302 with an internal diameter ofapproximately 0.022-0.024 inches, such that the clearances on each sidebetween the catheter shaft 302 and the stabilization wire 304 measureapproximately 0.001-0.002 inches at the proximal end and 0.003 inches atthe distal end.

With reference to FIG. 7, a cross section of the handle portion 103 isillustrated. FIG. 8 illustrates a close-up of this cross section. In apreferred embodiment, the grip 202 is connected to the stabilizationwire 304, although in some embodiments the stabilization wire 304 mayalso or instead be connected to the plunger 204. The stabilization wire304 is disposed within the catheter shaft 302, which preferably isconfigured to slide in a longitudinal direction over the stabilizationwire 304.

In certain embodiments, a crimp tube 305 may be used to connect thestabilization wire 304 to the grip 202. The crimp tube 305 is preferablyconstructed from a metal, for example stainless steel alloys (e.g.,SS304), that is harder than the stabilization wire 304 and formed as ahypotube. Preferably, the crimp tube 305 is crimped over the proximalend of the stabilization wire 304, with the proximal end of the crimptube 305 being held within the grip 202 and the distal end of the crimptube 305 being held within the remainder of the body of the plunger 204.In some embodiments, the crimp tube 305 may extend partially over thecatheter shaft 302, for example for a short length of 0.1 inches, asthis may provide additional buckling resistance to the catheter shaft302 when forces are applied to the catheter shaft 302. In someembodiments, the crimp tube 305 may have an internal diameter measuringapproximately 0.039 inches, with a wall thickness of 0.010 inches.

The catheter shaft 302 is connected via a fork 216 to the movable handle206. Because the movable handle 206 preferably is configured to slideback and forth along the plunger 204, and because the movable handle 206is coupled to the catheter shaft 302, movement of the movable handle 206will cause a corresponding movement of the catheter shaft 302 inrelation to the stabilization wire 304. As will be discussed below, thismovement may permit ejection and deployment of a device loaded in thedistal tip 107. Further, the locking lever 210 may be provided with alocking tab 222 that engages with a recess 220 on the movable handle206, thus helping reduce or eliminate the likelihood of the movablehandle 206 from sliding along the plunger 204. Such a provision can beused to help reduce or eliminate the unintended or premature deploymentof a device from the catheter system 101. In certain embodiments, thecatheter shaft 302 could instead be connected to the plunger 204, andthe stabilization wire 304 could be connected via the fork 216 to themovable handle 206.

The catheter shaft 302 preferably is secured to the handle portion 103,and in certain embodiments one or more intermediate components may formpart of this connection. In some embodiments, and with reference now toFIGS. 9A-B, the catheter shaft 302 may be secured to a fork-shapedintermediate component such as a fork 216, and may for example be heldin a recess in the fork-shaped intermediate component. This fork 216 isin turn connected to the movable handle 206. The movable handle 206 isomitted for clarity, but its relation to these other parts can be seenin FIGS. 7-8.

The fork 216 preferably comprises at least two prongs 217. These prongs217 have a space in between each other that is less than the diameter ofthe catheter shaft 302. In order to connect the catheter shaft 302 tothe fork 216, the catheter shaft 302, which preferably is constructedwith a circular cross-section, may therefore have one or more indents orcavities 308 formed thereon. This indent or cavity 308 permits thecatheter shaft 302 to be received in the space between the two prongs217, as the cavities 308 will, at that distance along the catheter shaft302, cause the catheter shaft 302 to have a smaller cross-sectionaldistance so as to permit the catheter shaft 302 to be inserted andsecured in the space between the two forks 217. Accordingly, an axiallysecure connection can be made between the catheter shaft 302 and thefork 216. As the stabilization wire 304 lies inside the catheter shaft302, care must be taken that the indents or cavities 308, 310 do notsubstantially interfere with the relatively free movement of or cut intothe catheter shaft 304.

Tests have shown that an embodiment of the fork 216 constructed fromstainless steel (the fork 216 may be constructed from any suitable rigidmaterial, for example metals including stainless steel) could withstanda force greater than 20 pounds before failure. Because a user isunlikely to be able to apply this much force during deployment, thisconstruction makes it more likely that the system 101 will remainintact, and that failure of the fork 216 is thus less likely to causethe catheter shaft 302 to detach from the remainder of the system 101.

Referring back to FIG. 1, an outer sheath 316 may also be provided overthe catheter shaft portion 105. The outer sheath 316 may be disposedbetween the catheter shaft 302 and the strain relief component 212, andmay serve (in addition to the strain relief component 212, if soprovided) to minimize kinking and torsional loading of the catheterportion 105. To ensure secure connection of the sheath 316, it may bepreferable to secure the sheath 316 to the plunger 204, for example byinsert molding or adhesives. In some embodiments, the outer sheathmeasures between 22 and 39 inches, with a wall thickness betweenapproximately 0.005-0.015 inches, preferably 0.010 inches. Preferably,the outer sheath 316 has a gap or clearance between itself and thecatheter shaft 302. In some embodiments, this clearance measuresapproximately between 0.003-0.010 inches, preferably 0.005 inches perside. In some embodiments configured to be sterilized (e.g., usingethylene oxide gas sterilization), the clearance between the cathetershaft 302 and the outer sheath 316 may be designed to permit adequateflow of sterilant between the two parts.

The outer sheath 316 preferably is constructed from materials includingpolymers such as HDPE, Nylon-12, PEBAX®, polyurethanes, or blendsthereof, for example in a single polymer extrusion. In some embodiments,the outer sheath 316 is co-extruded with two different materials. On theside of the outer sheath 316 facing the catheter shaft 302, a lubriciousmaterial may be used, for example HDPE, FEP, or another suitablematerial. On the outer side of the sheath 316, a polymer such as PEBAX®or Nylon-12, or another suitable material may be used to achieve abalance between factors such as pushability (e.g., limiting the amountof force a user can apply), mechanical strength (e.g., resistance toyielding while under load), kink resistance, friction with the inside ofthe bronchoscope, and manufacturability. In some embodiments,radioopaque materials, for example barium sulfate, may be incorporatedinto the sheath 316 and/or other elements of the catheter system 101.

With reference to FIGS. 10A-C, a series of cuts may be made alongsubstantially all or part of the catheter shaft 302. These cuts maydefine one or more regions 330 of increased flexibility that aretypically able to bend or flex better than a catheter shaft 302 leftuncut. In some embodiments, it has been found that the catheter system101 performs well if a portion of the distal end of the catheter shaft302 has a high flexibility region 330 cut into it, as the distal portionof the catheter shaft 302 may need to be bent to a greater extent inorder to navigate tortuous airway passages, for example. The flexibilityof the high flexibility region 330 may be tailored as desired for aparticular application. The flexibility can be changed, for example, bymodifying the thickness of the catheter shaft 302, the materials usedtherein, and the spacing, pitch, and angle between the cuts in the highflexibility region 330. Preferably, the cuts extend in a spiral fashionalong the catheter shaft 302.

Additionally, the high flexibility region 330 does not need to be of thesingle pitch illustrated in FIG. 10A, but, with reference to FIG. 10B,can instead be of a variable pitch, wherein the spacing or pitch can bechanged in a continuous or stepwise fashion. Additionally, although thecuts shown in these figures are made in a continuous and single cut,high flexibility regions may be made using one or more discontinuouscuts. In these figures, the cuts that constitute the high flexibilityregion 330 are made in a “jigsaw” configuration that forms a sawtooth orzigzag pattern. Other possible cuts are a “serpentine” configuration asillustrated and discussed below in FIGS. 16B and C. In this serpentineconfiguration, the cuts are smoother, more rounded, and with a longeramplitude than the jigsaw pattern. Other cut types are possible andenvisioned, including straight cuts, partial or dashed cuts, zigzagcuts, sinusoidal cuts, and so on.

FIG. 10C illustrates an embodiment of a high flexibility region 330comprising overlapping discontinuous straight cuts, each extendingaround approximately half of the circumference of the catheter shaft302. In this embodiment, punch holes 331 may be provided at one or moreof the ends of each cut. The punch holes 331 may in some cases be madeas part of a laser cutting process used to create the cuts, although thecuts may be made using any suitable process, for example chemicaletching. Punch holes 331 may also be useful in providing additionalstrength to the catheter shaft 302, as it is believed that the punchholes 331 may aid in reducing or eliminating the likelihood of crackpropagation when the catheter shaft 302 undergoes various stresses.

In practice, tailoring of the high flexibility region 330 and the cutsthat constitute this high flexibility region 330 may be desirable tofind the right balance between the flexibility required and the type ofcut. For example, while wider or larger cuts may provide additionalflexibility, these may in some cases weaken the catheter shaft 302 to anunacceptable extent. Different cut types may also perform more or lesssatisfactorily in fatigue testing. Additionally, certain cuts may causeportions of the high flexibility region 330 to abrade the workingchannel of the bronchoscope, although postprocessing after creation ofthe cuts may include steps such as deburring or ultrasonic cleaningwhich may at least partially alleviate such concerns. The type of cutsdescribed above may also be adjusted in accordance with the length ofthe one or more high flexibility regions 330.

In preferred embodiments, high flexibility regions 330 measuring 3 to 6inches, with the pitch between cuts measuring between 0.010 to 0.100inches, have been found to work well. The cut width (kerf) has beenfound in some embodiments to be satisfactory in the range between0.0015-0.0030 inches.

In certain embodiments, it may be preferable to cover at least the highflexibility region 330 with a flexible protective layer, for example apolymer or heat-shrink material. Such a protective layer can at leastpartially mitigate abrasion of the interior of the working channel of abronchoscope due to the cuts and also reduce or eliminate the likelihoodof damage or overstretching of the catheter shaft 302, which may aid inmaking the catheter usable for multiple deployments. Additionally, thisprotective layer may also be lubricious or lubricating, thus permittingthe catheter shaft 302 to slide more easily within a bronchoscopeworking channel.

With reference now to FIGS. 11A-B and 12A-B, the distal tip portion 107may be joined to the catheter shaft portion 105 via a connector 402.More specifically, in some embodiments this connector 402 connects theouter catheter shaft 302 to the distal tip portion 107. In a preferredembodiment, the distal tip portion 107 may comprise a cage 404, the cage404 being connected to the catheter shaft 302 via the connector 402.This cage 404 may be constructed from a sufficiently durable material ormaterials, including metals such as stainless steel and Nitinol. In someembodiments, the cage 404 may be constructed from pre-formed tubing, andsome other embodiments may have the cage 404 constructed from a flatportion of material which is then wound to form a tube, either in alengthwise or spiral direction.

The distal tip portion 107 preferably is configured to contain a cavity405 disposed within it, the cavity 405 being sized to contain a suitabledevice to be subsequently deployed. Preferably, the cage 404 comprisesthe cavity 405 disposed in a space within the cage 404.

In some embodiments, and as illustrated in FIGS. 11B and 12B, the cavity405 may contain a medical device such as a valve 500. In such cases, thevalve 500 may be loaded into the cavity 405 through the distal opening410 by using a valve loader apparatus of the type described in U.S. Ser.Nos. 12/249,243 and 12/422,179, each of which is hereby incorporated inits entirety. Once loaded into the cavity 405, the proximal end of thedevice (for example the valve 500) abuts against a pusher plunger 408,which is in turn connected to the stabilization wire 304. In use,proximal motion of the movable handle 206 in relation to the plunger 204in the handle portion 103 causes the cage 404 to retract relative to thepusher plunger 408, thereby releasing the device (such as valve 500)contained in the cavity 405 from the opening 410.

Fenestrations 409 are preferably disposed on at least a portion of thecage 404, and may serve the purposes of improving visibility of a devicedisposed therein as well as improving flexibility of the distal tipportion 107. The remaining struts 411 form a cage or frame-likestructure, and may comprise a spiral or staggered spiral pattern,although different configurations and patterns are possible. Thefenestrations 409 may be, for example, laser-cut. Other methods, such asphotochemical milling, may also be employed.

Preferably, the cage 404 also contains one or more large fenestrations413. This large fenestration 413 may be useful in visualizing a devicedisposed within the cavity 405, as well as confirming that a device hasbeen properly or correctly loaded in the cavity 405. The largefenestration 413 may also be useful in providing a clear area forlocating a marker band or other localization marker (discussed infurther detail below). Preferably, the entire cage 404 is constructedfrom a single piece of material, and the distal portion of the cage 404comprising the rim 415 may be connected to the proximal section of thecage 404 via longitudinal struts 414.

In the manufacture of the distal tip portion 107, it may be advantageousto coat inner and/or outer portions of the distal tip portion 107 andthe cage 404. For example, coating with a softer material, for example apolymer, may be useful to avoid injury to bodily tissue when using thecatheter, as well as helping the distal tip portion 107 to slide freelywithin the working channel of a bronchoscope or other instrument.Additionally, coating the inner portion of the catheter may help inreducing or eliminating the likelihood of damage to a medical deviceloaded therein, or snagging of the medical device during deployment.

Thus, certain embodiments provide for providing a liner, consisting forexample of a polymer such as polytetrafluoroethylene, disposed on atleast a portion of the inner surface cage 404 or cavity 405, incombination with a liner disposed on at least the outer surface of thedistal tip 107 portion, which may consist of a polymer such as PEBAX®.

In some embodiments, these coatings or liners may be reflowed onto thedistal tip portion 107. Using a mandrel, heating may be applied toreflow these liners over the metal portion of the distal end 302.Preferably, the liners chosen are at least partially transparent overthe fenestrations 409, 413 such that a medical device loaded therein canbe inspected. Different polymers and polymer types may be used alongdifferent portions of the distal tip 107, where for example atransparent polymer is used along only one portion of the distal tip107, while an opaque or pigmented polymer is used along a differentportion of the distal tip 107, permitting the catheter to bespecifically tailored to the desired application and use. As discussedbelow and in FIG. 15, such polymer coating and reflowing may alsoincorporate localization markers onto or into the distal tip portion107. Different methods may be used to coat the distal tip portion 107,including dip coating, extrusion, applying heat shrink materials, and soon.

In a preferred embodiment, the rim 415 surrounding the opening 410located at the distal end of the distal tip portion 107 is configured tobe smooth and atraumatic, so as to reduce or eliminate the likelihood ofinjury to body tissue during insertion and deployment of a devicelocated in the cavity 405.

Preferably, and with reference to FIG. 13, the rim 415 comprises aseries of small welds arranged circumferentially around the opening 410,and which may for example be made using laser welding so as to provide asmooth, rounded end. In such a case, the rim 415 may thus be configuredto provide an atraumatic tip that minimizes snagging or other engagementwith a device that may be deployed from the cavity 405, while also beingdurable and capable of sustaining multiple uses. In other embodiments,the rim 415 may be covered with a layer of polymer or other softmaterial.

Referring back now to FIGS. 11A-B and 12A-B, in some embodiments theconnector 402 may be seam-welded along the boundary joining theconnector 402 to the distal tip portion 107, via either the cage 404 orthe distal end of the catheter shaft 302. Such a weld is preferable asit provides for a smoother transition from the catheter shaft portion105 to the distal tip portion 107, thereby reducing operator effort andhelping provide for smooth, continuous movement of the system 101 duringdeployment. Spot-welding may be used as well, although care should betaken to reduce the size of the spot weld from excessive protrusion, asthere could be a risk that such a weld may catch or snag within abronchoscope.

With reference to FIG. 14, certain embodiments may provide for theconnector 402 to be constructed from a multi-part design. In suchembodiments, a compression cone 430 is attached, for example by welding,to the distal end of the outer catheter shaft 302. A ferrule 432 isattached, for example by welding or simply through mechanicalinterlocking, to the distal end 402, which may then be pushed over thecompression cone 430 so as to sandwich the proximal end of the cage 404.This interlocking connection comprises connector 402, and forms a strongconnection capable of resisting most pulling forces. Samples have beentested to withstand a pulling force of at least 100 N.

Turning now to FIG. 15, an embodiment of the system 101 may be providedwith localization markers. These localization markers may be provided,for example, on parts of the distal tip portion 107 and the distal endof the catheter shaft portion 105. Generally, localization markers aidan operator in ascertaining the position of the system 101 in relationto external objects. The localization markers may be visual, and maythus be useful while in a limited-visibility environment such as thefield of view as seen through a bronchoscope. More specifically,localization markers may be helpful for selecting and indicating anappropriate deployment site for a medical device loaded in a catheter,and may also be useful in allowing an operator to determine if acatheter has been extended too far out of, for example, a bronchoscope'sworking channel or other delivery device.

Certain embodiments may be provided with one or more localizationmarkers, such as lines 445, 446, 447, which may aid in selecting andindicating an appropriate deployment site for a medical device loadedinto the catheter. Here, when the catheter containing a device is loadedinto a bronchoscope and guided to a portion of the body requiringtreatment (for example a lung airway), an operator may use the line 445to align the catheter with the site where the medical device is to bedeployed, as the line 445 will denote the approximate location where themedical device will be released from the opening 410. In someembodiments, the device may be a valve 500 for deployment in an airway,and in such cases, the line 445 will generally align with the airpassageway region that the membrane of the valve 500 will seal against.These embodiments are described in further detail below and in FIGS.20A-C.

The line 445 may be particularly useful to aid in visualization of anappropriate deployment site through a bronchoscope viewing channel, andsome embodiments provide for the line 445 to be surrounded or flanked byadditional black or differently-contrasting bands of color 446, 447 toprovided additional contrast. Although the line 445 may be marked on thedistal tip portion 107 with any appropriate means, such as pad printingor inkjet printing, biocompatibility concerns may sometimes necessitatethat the line 445 not employ exposed pigments in its construction. Insuch cases, some embodiments may use a marker band placed around thedistal tip portion 107. Such a marker band may consist of a polymerband, for example constructed from a heat-shrinkable polymer such asPEBAX®. As a yellow line 445 has been found to be advantageous incertain applications, a gold-colored marker band may be slipped onto thedistal tip portion 107. The marker band may be composed from anysuitable material, and preferably is highly visible. Materials such asgold or platinum with iridium are materials that have been found to beacceptable. Optionally, a marker band serving as a line 445 may beencapsulated below the liner described in the reflowing process above,or may be encapsulated under an additional and preferably at leastpartially transparent layer of polymer, such as PEBAX®.

In some embodiments, the line 445 or other localization markers may beformed by cutting a line or series of perforations into the distal tipportion 107, such that no additional materials are required to form therespective localization markers. Further, although the line 445 isdescribed above as being disposed on the distal tip portion 107, otherembodiments may place the line 445 on other portions of the system 101.For example, a line 445 may be made on the stabilization wire 304 orplunger 408, with an associated aperture or window cut into the distaltip portion 107 if necessary to permit visualization of the line 445.

In addition, certain embodiments may provide for a long localizationmarker 448 disposed, for example, on a distal portion of the cathetershaft 105. This long localization marker 448 may be used as a warningfeature to an operator that the catheter system 101 has been extendedtoo far past the bronchoscope. This long localization marker 448preferably is pigmented or colored, for example in a contrasting colorsuch as yellow, so as to be readily visible by an operator should thecatheter be extended past the bronchoscope. The long localization marker448 may be placed onto the catheter shaft 105 using any suitable means,including the ones described previously for the lines 445, 446, 447.Preferably, the long localization marker 448 may be constructed from asuitable heatshrink polymer, which may in some cases be subsequentlycovered by a clear or unpigmented protective polymer layer. In someembodiments, the long localization marker 448 may measure between 5 and10 inches, and preferably six inches, and may be located approximatelytwo inches from the distal tip.

Although the localization markers discussed above refer primarily tovisual indicators, localization markers used in the system 101 may beconfigured for localization using other means. For example, any of thelocalization markers or lines 445, 446, 447, 448 may be constructed fromor incorporate a radioopaque material (e.g., barium sulfate) forlocalization using radio imaging methods. In an MRI-compatibleembodiment of the system 101, MRI contrast agents could also beincorporated into the localization markers. Active (powered) or passive(e.g., passive RFID) localization beacons may also be incorporated intothe distal tip portion 107, which may function in addition to or toreplace the localization markers discussed above, and which couldfunction in conjunction with mapping software so as to track thelocation of the distal tip portion 107 in real time and withoutnecessarily requiring visual confirmation of the position of the distaltip portion 107 with respect to a deployment site. These localizationmarkers may also be hybrid localization markers combining multiplelocalization methods, such as localization markers that are bothradioopaque and visual.

FIGS. 16A-H illustrate different embodiments of the distal tip portion107. Although these designs may share several similarities with FIGS.11A-B and 12A-B, additional differences and features will be discussedherein. Turning first to FIG. 16A, an embodiment of the distal tipportion 107 is shown that comprises a staggered spiral configuration inthe cage 404 (as contrasted with the continuous spiral or helixconfiguration illustrated in FIGS. 11A-B). The additional materialpresent, and which links the struts 411 together, may provide addedstrength against external and internal forces that may be applied to thetip while in use (e.g., torsional or bending forces). In a preferredembodiment, the cage 404 may be constructed from a sheet of Nitinol,chemically etched, and rolled to a cylindrical shape.

Additionally, the connector 402 is provided here with a multi-partconnector similar to that described above in relation to FIG. 14.Localization markers including line 445 may also be present. Asdiscussed previously, this embodiment comprises a high flexibilityregion 330 with a jigsaw cut configuration on the catheter shaft 302.

FIG. 16B illustrates a similar embodiment with a different highflexibility region 330 on the catheter shaft 302, this time formed in aserpentine design.

Turning now to FIG. 16C, this embodiment comprises a high flexibilityregion 450 that has been integrated onto the distal tip portion 107 andis otherwise similar to the high flexibility region 330 illustrated inFIG. 16A, except that the region 450 here is on the distal tip portion107. The high flexibility region 450—here, made in a serpentine cutconfiguration—connects to the catheter shaft portion 105 via a connector402, and connects to the cage 404 via a second connector 403.Additionally, some applications may entail adding another additionalhigh flexibility region 330 of the type previously described in additionto the high flexibility region 450 illustrated here to the cathetershaft 302. In some cases, the interior of the high flexibility regionand/or the cage region may be lined with PTFE or other lubriciouspolymers to minimize buckling of the stabilization wire that extendsthrough the finished catheter.

FIG. 16D illustrates another embodiment of the distal tip portion 107that is similar to the embodiment described in FIG. 16C. Here, the highflexibility region 450 comprises a jigsaw design.

FIG. 16E illustrates an embodiment of a distal tip portion 107 similarto the embodiment illustrated in FIG. 11A, with the cage 404 comprisinga spiral configuration. Here, the high flexibility region 330 disposedon the catheter shaft 302 comprises overlapping discontinuous straightcuts, each extending around approximately half of the circumference ofthe catheter shaft 302. These cuts may be similar in configuration tothose illustrated in FIG. 10C. Because these cuts are discontinuous,some embodiments of the resulting high flexibility region 330 may haveadditional strength compared to other high flexibility region typesillustrated herein.

FIG. 16F illustrates an embodiment of the distal tip portion 107 thatcomprises a tapered portion. Here, the cage 404 is connected via asecond connector 403 to a tapered portion 452 which tapers to a smallerdiameter toward its proximal end. The tapered portion 452 is connectedto the catheter shaft 302 via a connector 402, and may be provided witha high flexibility region 330 similar to those previously described. Insome embodiments, the tapered portion and/or the cage may be formed byproducing a helical wrap from sheet stock of a rigid material such asNitinol that has been photochemically etched (although different metalsor materials may be employed). Some advantages of this taperedembodiment may include smoother movement of the catheter system 101through a bronchoscope working channel.

FIG. 16G illustrates another embodiment of the distal tip portion 107that comprises a different tapered portion. Here, the cage 404 itself isformed as a single unit (contrasted with FIG. 16E) and tapers to asmaller size toward its proximal end. Such a cage design may be in somecases cheaper to manufacture and assemble compared to the multi-piecedesign of FIG. 16E, and may in some cases be photochemically etched froma single sheet of nitinol, and subsequently rolled to shape. This singlepiece tapered embodiment may also be manufactured so that the staggeredspiral configuration illustrated here does not extend as far proximallyas illustrated here, so that such an embodiment may resemble theembodiment illustrated in FIG. 16F without a second connector 403.Preferably, the cage 404 is attached to the catheter shaft portion 105using a connector 402 of the type described above in FIG. 14. As withFIG. 16F, a high flexibility region 330 (here, of the “jigsaw” type) maybe present on the catheter shaft 302.

FIG. 16H illustrates a different configuration for the cage 404 that maybe used in certain embodiments of the distal tip portion 107. Here,rather than a spiral or helical configuration, the cage 404 may beformed with a braided configuration as illustrated. Such a configurationpreferably is laser cut, although different manufacturing methods suchas photochemical milling are also possible. The configuration of thisembodiment of cage 404 may be advantageous in applications requiringadditional flexibility in the distal tip region 107. In someconfigurations, for example when the cage 404 is constructed fromnitinol, a nitinol compression ring may be used to secure the cage 404to the catheter shaft portion 105 rather than the connector 402 or theconnector type described in FIG. 14.

With reference now to FIG. 17, the catheter system 101 may be packagedwith a tube 110 serving to protect the catheter shaft portion 105 anddistal tip portion 107. A valve loader 115 may also be provided, whichserves to load valves or other medical devices into the distal tipportion 107. Examples of such valve loaders 115 are described in U.S.Ser. Nos. 12/249,243 and 12/422,179, each of which is herebyincorporated in their entirety. The entire system 101 and valve loader115 may be packaged together using the packaging 118, and together forma kit 120.

FIG. 18A illustrates a possible use of the catheter system 101. Here,the catheter system 101 may be inserted into a working channel 511 of abronchoscope 510. The bronchoscope 510 may be a commercially availablemodel, such as the BF-P180 made by Olympus. Preferably, such abronchoscope will be provided with at least a 2.0 mm working channel, inaddition to a visualization channel permitting navigation of thebronchoscope into a patient airway 601 leading into lungs 600. Ofcourse, endoscopes other than bronchoscopes may be used for differentprocedures, and such endoscopes will preferably be provided with atleast a 2.0 mm working channel. Endoscopes (including bronchoscopes)used with the system 101 will preferably not exceed a length of 110 cm.

FIG. 18B illustrates an alternative method of using the catheter system101 with the bronchoscope 510. Here, the grip 202 can be clipped onto apart of the bronchoscope 510 as illustrated, with the bronchoscope beingreceived within a recess in the grip 202. Some embodiments of the grip202 may be constructed so to form a C-handle, which may advantageouslypermit a more secure connection to be made with the bronchoscope. Afterthe grip 202 is secured to the bronchoscope 510, the catheter shaftportion 105 and distal tip portion 107 are inserted into the workingchannel 511 of the bronchoscope 510. In some embodiments, it may beadvantageous to use a Tuohy-Borst adapter 515 as presently illustrated.As the Tuohy-Borst adapter 515 aids in securing the outer cathetersheath 316, accuracy in placement of the device may not require a secondperson or other securement method to pinch or hold the catheter sheathduring deployment.

FIGS. 19A-C illustrate the use and disengagement of an embodiment of alockout mechanism that may be used in certain embodiments describedherewith. FIG. 19A represents an initial configuration of the handleportion 103 that the system 101 preferably is provided with subsequentto loading a valve or other medical device therein. Here, the lockinglever 210 is in the locked position, which in this embodiment occurswhen the locking lever 210 extends distally in relation to thesecurement tab 208. As illustrated in FIG. 8 and described above, whenthe locking lever 210 is in this position, the locking tab 222 attachedto the locking lever 210 is engaged with the recess 220 on the movablehandle 206, thus reducing or eliminating the likelihood of the movablehandle 206 moving.

FIG. 19B illustrates the system 101 in an unlocked (but undeployed)position. Here, the locking lever 210 has been pushed toward thesecurement tab 208, in this case by pivoting the locking lever 210 aboutthe pivot point 226. When in this position, and again with reference toFIG. 8, the locking tab 222 pivots or moves downward and becomesdisengaged from the recess 220 on the movable handle 206, thuspermitting the movable handle 206 to be slid axially in a proximallongitudinal direction toward the grip 202.

FIG. 19C illustrates the configuration of the handle portion 103 afterthe deployment of a device loaded in the distal tip 107. Here, themovable handle 206 has been slid or moved axially in a proximallongitudinal direction toward the grip 202. Some embodiments may providefor the locking lever 210 to automatically reset to a locked position.For example, after the movable handle 206 moves past the end of thelocking tab 222, a spring or other restoring force may push or pivot thelocking lever 210 back toward a locked position, for example via aspring 228 attached under the locking tab 222 (as illustrated in FIG.8). Accordingly, should a user slide the movable handle 206 back in adistal direction, the handle portion 203 will have been automaticallyreset to the configuration illustrated in FIG. 19A, thus permittingdeployment of another device without necessitating the user to rememberto reset the lockout lever 210.

FIGS. 20A-C show an embodiment of catheter system 101 with a valve 500loaded within a cavity 405 in the distal tip portion 107. Note thatseveral structural elements have been depicted in ghosted lines or arenot illustrated for the sake of clarity. The catheter system 101 hasbeen inserted into a bronchoscope (not shown), and the bronchoscope isguided to a portion of a lung requiring treatment, which in this case isan airway 601.

In determining an appropriate deployment site for the valve 500 (here,denoted as deployment site 606), an operator may use the line 445 toalign the distal tip portion 107 with the site 606 where the valve willbe deployed, as the valve 500 will be released from the distal end 410of the catheter at the approximate location denoted by the line 445. Insome embodiments, the line 445 generally aligns with an air passagewayregion that the valve 500 will seal against, and can thus be alignedwith a desired deployment site 606. The lines 446, 447 that flank theline 445 are preferably darker- or black-colored so as to provideadditional contrast to allow an operator to easily see the line 445through a bronchoscope viewing port. Moreover, in use an operator canextend the catheter distally beyond the line 447 and then retract thecatheter proximally until reaching the line 445. While retracting thefirst line 447 encountered can be used as a landmark indicating that theline 445 is approaching. If so provided, a long localization marker 448present on the distal portion of the catheter shaft portion 105 (asdescribed in FIG. 15) may also be advantageous as another safety featureto ensure that the operator does not extend the catheter too far pastthe bronchoscope.

With the line 445 aligned with the desired deployment site 606, and withthe locking lever 210 moved to its unlocked position, the operator pullsthe movable handle 206 in a proximal direction toward the grip 202 (seegenerally FIGS. 19A-C). This deployment movement retracts the cathetershaft 302 and cage 404, while the stabilization wire 304 remainsgenerally stationary. The pusher plunger 408 at the end of thestabilization wire 304 preferably is configured to contact a central rod502 of a valve 500 inserted into the cavity 405, thereby maintaining thevalve 500 in substantially the same position while the cage 404 isretracted around it. Freed from the catheter through the distal opening410, the anchors of the valve 500 expand to make contact with the airpassageway 601's wall, and the valve 500 expands so that the apex of itscup portion makes contact generally at the site 606 selected along thelung airway 601. This deployment method is useful as it permits a deviceto be deployed very close to the selected deployment site 606 byalignment with the line 445. Because the distal tip portion 107 retractsaround the device (such as the valve 500), such a device can bepositioned and deployed more accurately than other prior art deviceswhich simply eject a device from the distal end of a catheter.

Some embodiments of the catheter system 101 may also conform to certainbenchmarks and specifications in order to function acceptably in certainsituations and applications. For example, in an embodiment of the system101 being used to deploy a valve in an airway, and as described above,the system 101 will be partially inserted into the working channel 511of a bronchoscope 510. Because the bronchoscope 510 will be inserted andnavigated through tortuous airways of a patient, the system 101 withinit must be able to flex sufficiently and withstand the forces that willbe applied to it, which include torsional, bending, and kinking forces.Preferably, the system 101, and in particular the catheter shaft portion105, is configured to balance the need to be sufficiently rigid so as totransmit forces used to navigate the system 101 to a suitable deploymentsite while being flexible enough to navigate through tortuous spaces andreduce the likelihood of injuring or perforating an airway wall ifextended past the bronchoscope working channel. Further, the system 101preferably is designed so that a possible failure of any component willnot leave parts within a patient.

As the system 101 will typically encounter tensional or pulling forcesduring operation, the distal tip portion 107 preferably is configured toremain attached to the catheter shaft portion 105 to reduce or eliminatethe likelihood of leaving portions behind in a patient. The distal tipportion 107 is also preferably resistant to kinking of the cage 404 orother components thereof, as this may affect successful delivery anddeployment of medical devices loaded therein.

As illustrated in FIGS. 19A-C and 20A-C, embodiments of the system 101are preferably configured such that its components cause minimal bindingand resistance to movement during insertion and manipulation in abronchoscope as well as during deployment of a device loaded in thedistal tip portion 107. The exterior of the catheter shaft portion 105and the distal tip portion 107 are both preferably configured to berelatively smooth and cause minimal friction, such that these componentsmay slide freely in a bronchoscope working channel. Further, thefriction between the stabilization wire 304 and the interior of thecatheter shaft 302 and/or distal tip portion 107 should preferably beminimized as well. Preferably, the force required to overcome thefriction of a device (such as a valve 500) loaded in the cavity 405 ofthe distal tip 107 should be less than the force that can be appliedthrough the handle portion 103 by deploying the system 101 as discussedin FIGS. 19A-C and 20A-C. Such embodiments, when configured in thismanner, may provide for a smoother, more accurate deployment of a deviceto a target site.

In use, a user will insert the bronchoscope 510 into the lung of apatient to be treated with a device to be deployed from the cathetersystem 101. Then, the catheter system 101 (with a device such as a valve500 having been preloaded into the cavity 405 of distal tip 107) isinserted into the working channel 511 of the bronchoscope 510. Afterselecting and navigating to a suitable deployment site, and withreference now to FIGS. 19A-C, the locking lever 210 is moved to itsunlocked position.

After verifying the position of the distal tip portion 107 in relationto the deployment site, which may include aligning the desireddeployment site with any localization markings such as line 445(illustrated in FIG. 15), the user slides the sliding barrel 206 in aproximal direction toward the grip 202, thereby deploying the medicaldevice (such as the valve 500) in the deployment site at the airway ofthe patient.

In some embodiments, the accuracy of the catheter device deployment maybe increased by pinching or otherwise securing the outer sheath 316 onthe catheter shaft portion to keep the stabilization wire 304 in arelatively stationary position while the catheter shaft 302 retractsproximally. In a preferred embodiment, the catheter 101 may be removedfrom the bronchoscope working channel 511, and the movable handle 206returned to its initial position so as to be reloaded with anotherdevice. Thus, multiple device deployments may be made into a patientairway without necessarily having to remove the bronchoscope 510 fromthe lungs 600 of a patient.

It will be understood that the present illustration of the cathetersystem 101 being deployed into a lung is not limiting, and that thesystem 101 may be used for deployment of various devices into otherlocations on a patient, including gastric, endoscopic, or other suitablelocations. Similarly, a bronchoscope is not necessary, and othersuitable devices capable of accommodating the system 101 and beingguided to a deployment location may also be used, including withoutlimitation various endoscopes or laparoscopic cannulas.

Although this invention has been disclosed in the context of certainembodiments and examples, those skilled in the art will understand thatthe present invention extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinvention and obvious modifications and equivalents thereof. Inaddition, while several variations of the invention have been shown anddescribed in detail, other modifications, which are within the scope ofthis invention, will be readily apparent to those of skill in the artbased upon this disclosure. It is also contemplated that variouscombinations or sub-combinations of the specific features and aspects ofthe embodiments may be made and still fall within the scope of theinvention. It should be understood that various features and aspects ofthe disclosed embodiments can be combined with, or substituted for, oneanother in order to form varying modes or embodiments of the disclosedinvention. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

What is claimed is:
 1. A method of deploying a medical device in apatient lung, the method comprising: loading the medical device into acavity disposed in the distal tip portion of a deployment catheter,wherein the medical device comprises a valve having a membrane;introducing the deployment catheter into a bronchoscope; inserting thebronchoscope into a lung airway; navigating the bronchoscope to aportion of the lung airway to be treated; aligning the portion of thelung airway to be treated with at least one localization marker disposedon the distal tip portion of the deployment catheter, wherein the atleast one localization marker comprises at least one line positioned onthe deployment catheter to indicate a location in the lung airway wherethe membrane of the valve will seal against; unlocking a locking leveron the deployment catheter; deploying the medical device to the portionof the lung airway to be treated, wherein the deployment cathetercomprises a C-shaped handle on its proximal end, the C-shaped handleincluding an inner diameter value that is based on an outside diametervalue of the bronchoscope; and receiving the bronchoscope within theC-shaped handle, wherein the C-shaped handle receives the bronchoscopearound a longitudinal axis of the bronchoscope distal from a workingchannel port, wherein when the C-shaped handle is attached to thebronchoscope, a longitudinal axis of a proximal end of the bronchoscopeand a longitudinal axis of the proximal end of the deployment catheterform a 90 degree angle and intersect.
 2. The method of claim 1, whereinthe locking lever is reset to a locked position after deployment of thedevice.
 3. The method of claim 1, wherein the step of navigating thebronchoscope further comprises tracking the deployment catheter usingradio imaging means.